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tDCS and the Cardiovascular System in Community-dwelling Elderly.

Assess Transcranial Direct Current Stimulation for Cardiovascular and Locomotor Outcomes in the Community-dwellers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07573800
Enrollment
36
Registered
2026-05-07
Start date
2026-05-01
Completion date
2027-01-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-dwelling Elderly

Keywords

tDCS, cardiovascular, locomotor units, community-dwellers, elderly

Brief summary

This study could contribute to the advancements in healthcare by exploring the innovative intervention, which is Transcranial Direct Current Stimulation (tDCS). Investigating its impact on cardiovascular and locomotor outcomes could give rise to new non-pharmacological interventions for health promotion, disease prevention, and rehabilitation.

Detailed description

Age-related functional decline occurs in various organs like the cardiovascular system, brain, muscles, lungs, kidneys, and immune system in the body, contributing significantly to the onset of frailty in elderly individuals. Due to routine degeneration of aging, physical impairments related to movement take place, which include strength, balance, gait, and performance issues (5). Cardiovascular autonomic regulation is considered an important factor in health, while the autonomic nervous system is important for adapting therapy for prolonged cardiovascular outcomes. The process of aging can produce pathological changes in the cardiovascular system, whose results may lead to CVD. One of the main changes of aging is the augmented stiffness of central arteries, known as vascular aging. It occurs due to loss of elastic fibers and accumulation of collagen in the major elastic arteries, which leads to an increase in systolic and pulse pressures of healthy elderly individuals. These hemodynamic changes in vessels lead to clinical illness and increase the risk of developing hypertension, atherosclerosis, and stroke. While some other studies have shown that aging is also related to continuous decline in exercise capacity, walking ability, and physical function, impacting the performance of daily activity and maintaining personal independence. Walking limitation is very frequent in the elderly population, estimated at 58.1% to 93.2%, which can be a functional dependence risk factor among community dwellers. While increasing walking ability impacts several aspects of health-related quality of life, including physical, social, and emotional well-being. tDCS has a considerable impact on neuroplasticity and hypotension by delivering new interventional strategies to control blood pressure.

Interventions

OTHERtDCS

The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.

OTHERSham stimulation

Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Able to ambulate independently (with or without assistive device) * Cognitively intact (MoCA score ≥ 24) * PAR-Q

Exclusion criteria

* History of seizures or epilepsy * Implanted metallic or electronic devices (e.g., pacemakers, ICD) * Uncontrolled hypertension (\>180/110 mmHg) * Severe cardiac, pulmonary, neurological, or orthopedic disorders limiting participation * Active skin conditions at electrode sites * Recent hospitalization (\<3 months) * Ongoing hormonal therapy, anticoagulants, or psychotropic medications

Design outcomes

Primary

MeasureTime frameDescription
10-Meter Walk Test (10MWT)baseline, week 1, and week 5The 10MWT is broadly used in preventive care and rehabilitation centers; it is evaluated by measuring participant speed and counting the number of steps taken within a given time period. This measurement method includes walking a certain section set on a smooth floor at the normal or maximum speed. After this, walking time and number of steps taken are to be measured
Blood Pressure Monitorbaseline, week 1, and week 5A sphygmomanometer is used to measure systolic and diastolic blood pressure before and after intervention sessions. The modified sphygmomanometer showed excellent test-retest reliability with an intraclass correlation coefficient (ICC) of 0.996.
6-Minute Walk Test (6MWT)baseline, week 1, and 5It is a sub-maximal exercise test used to assess aerobic capacity and endurance. Any change in performance capacity are determined based on the distance covered in six minutes. The 6MWT is a practically performed simple test that requires a 100-ft hallway but no exercise equipment needed. It helps to evaluates the global and integrated responses of all the systems involved during exercise, including the cardiovascular and pulmonary systems, systemic and peripheral circulation, blood, neuromuscular units, and muscle metabolism
Short Physical performance batterybaseline, week 1, and 5It consists of 3 timed components: 1) a 4-m usual pace walk, 2) a 5-repetition chair stand without using one's arms, and 3) a progressive test of standing balance. It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. The final total SPPB scores ranged between 4 and 12, with 4 to 6 representing the low, 7 to 9 the middle, and 10 to 12 the best performance.
Heart rate variability (HRV)baseline, week 1, and 5Heart Rate Variability (HRV) in community-dwellers is a critical, non-invasive marker of autonomic nervous system function, with lower HRV values consistently predicting higher cardiovascular risk, mortality, and functional decline. Among community-dwelling older adults, reduced HRV is strongly associated with adverse health outcomes such as frailty, cognitive impairment, and depression.

Secondary

MeasureTime frameDescription
tDCS Safety Screening Questionnairebaseline, week 1, and 5Used to assess the safety and suitability of participants for tDCS intervention by assessing different potential risks. It includes medical history, medication, skin sensitivities, neurological conditions, and mental health.

Countries

Pakistan

Contacts

CONTACTNimra Irshad, DPT
nimrairshad225@gmail.com00923157338975
CONTACTMirza Obaid Baig, MSPT
obaid.baig@riphah.edu.pk00923332238706
PRINCIPAL_INVESTIGATORMirza Obaid Baig, MSPT

Riphah International University

PRINCIPAL_INVESTIGATORSumaiyah Obaid, MSPT

Riphah International University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026